CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
EMA + App/Treatment Messagesbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03746808
NCT03746808N/ACompleted

Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention

University of North Texas Health Science Center·interventional·Posted Nov 20, 2018·Updated Nov 18, 2022

In Brief

A clinical study evaluating EMA + App/Treatment Messages for Alcohol Use Disorder and 2 related conditions. Completed, enrolled 119 participants across 1 site.

Detailed Summary

Homeless adults are 8 times as likely to be alcohol dependent compared with adults in the general population, yet few studies have examined the precipitants of alcohol use in this vulnerable population. Ecological momentary assessments (EMAs) that involve repeated assessment of thoughts/mood/behaviors (e.g., via smart phone) is currently the most accurate way to assess individuals in real-time in their natural environments. Advances in smartphone technology also allow for the collection of continuous geolocation and other passive sensing data. Thus, researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone. Building on prior work, this study will use a three-phase study to develop and test a "just in time" adaptive intervention to reduce alcohol use in homeless men and women. Phase I will use smartphones and passive sensing technologies to monitor geolocation, psychosocial variables (e.g., stress, affect, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment. Phase I will identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use over 4 weeks. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent drinking. The resulting app will assess imminent risk of alcohol use after each EMA and will deliver relevant treatment messages that match a person's current risk factors. Phase III will test the feasibility, acceptability and preliminary efficacy of the app in a sample of 40 homeless adults with an AUD who receive the EMA plus treatment messages over 4 weeks. Drinking will be determined via self-report, supplemented by a transdermal alcohol sensor (i.e., SCRAM) worn by participants. This project will be the first to combine geolocation and psychosocial variables to identify real-time antecedents of drinking. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with alcohol use disorders.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 20, 2018
Enrollment StartFeb 14, 2019
Primary CompletionJul 30, 2021
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.6 years ago

Interventions

EMA + App/Treatment Messagesbehavioral

This study will develop and test a "just-in-time" adaptive intervention to reduce alcohol use among homeless adults. Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are enrolled in shelter-based treatment. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use.